Regulatory calendar
A chronological view of recent and upcoming Vietnamese regulatory milestones across pharma, cosmetic, food and medical practice. Each milestone shows the governing document, affected product kinds and a link to a Medibase deep-dive article when one exists.
| Effective date | Document ID | Name | Affected kinds |
|---|---|---|---|
| 2024-11-21 | Luật 44/2024/QH15 | Pharmacy Law amendment passed | drug |
| 2025-07-01 | Luật 44/2024/QH15 | Pharmacy Law amendment effective | drug |
| 2025-07-01 | NĐ 163/2025/NĐ-CP | Decree implementing the amended Pharmacy Law in force | drug |
| 2025-07-01 | TT 31/2025/TT-BYT | Drug-registration procedure circular | drug |
| 2025-07-01 | TT 28/2025/TT-BYT | GMP for drug manufacturing — refreshed | drug |
| 2025-07-01 | TT 11/2025/TT-BYT | Good Pharmacy Practice — consolidated text | drug |
| 2025-10-25 | TT 40/2025/TT-BYT | Public-hospital drug procurement — refreshed | drug, tender |
| 2025-12-31 | Hague Apostille Convention 1961 | Vietnam deposits accession to the Hague Apostille Convention | medical_device, drug, treaty |
| 2026-02-27 | TT 50/2025/TT-BYT | Clinical-trial application procedure refreshed | drug |
| 2026-06-01 | TT 18/2026/TT-BYT | Special-control medicines circular signed | drug |
| 2026-07-16 | TT 18/2026/TT-BYT | Special-control medicines — full effect | drug |
| 2026-09-11 | Hague Apostille Convention 1961 | Hague Apostille Convention in force for Vietnam | drug, medical_device, treaty |
| 2026-10-01 | Thông tư 32/2026/TT-BYT | Circular 32/2026/TT-BYT — new drug-registration framework in force | drug |
| 2027-07-01 | TT 32/2025/TT-BYT | Traditional-medicine licensing fully delegated to provinces | drug |
National Assembly passes the Pharmacy Law amendment (amends Luật Dược 105/2016); takes effect 1 July 2025.
Automatic-extension safety net for in-flight renewals, explicit reference-dossier pathway for SRA-approved products, 3-month renewal window (down from 12), dedicated innovative-drug pathway.
Implements Law 44/2024: special-control drug classification, storage / production / distribution rules, FIE notification regime (Art. 91 §12).
Operational circular for Luật Dược Chapter IV — dossier modules, timelines, expert-council process.
Replaces Circular 35/2018/TT-BYT with an updated GMP framework aligned to PIC/S developments.
Consolidated GPP text integrated with the electronic drug-records requirement.
Vietnam deposits the instrument of accession to the 1961 Hague Apostille Convention; replaces consular legalisation for most public documents from foreign signatories — major simplification for FSC / CPP / GMP packs.
Replaces Circular 50/2018; tightens timelines and aligns with ICH expectations for first-in-human and reference-product trials.
Implementing circular for the special-control medicines regime. Etomidate and Carisoprodol reclassified as psychotropic effective immediately on signature; other provisions wait for 16 July 2026.
Procedures, storage rules, prescription / dispensing / disposal controls under TT 18/2026/TT-BYT all become active.
Apostille replaces consular legalisation for public documents from other signatories — direct simplification for FSC / CPP / GMP and medical-device technical files.
Replaces Circular 12/2025/TT-BYT as the operational rulebook for marketing authorisation of chemical drugs, vaccines, biologicals, herbal medicines, and pharmaceutical starting materials. Traditional medicine (thuốc cổ truyền) continues under Circular 29/2025/TT-BYT — not in scope of 32/2026. Transitional provisions for in-flight dossiers filed before 1 October 2026 expected in DAV implementation guidance.
End of the 12-month transition (from 1 July 2026) — registration of vị thuốc cổ truyền and dược liệu is fully handled at the provincial Sở Y tế.
